Trial | NCT00002897  Report issue

Title

Surgery With or Without Chemotherapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus
RANDOMIZED STUDY OF PREOPERATIVE CHEMOTHERAPY VERSUS SURGERY ALONE IN ESOPHAGUS CANCER

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    240
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether chemotherapy before surgery is more effective than surgery alone in treating cancer of the esophagus.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients with stage II or stage III cancer of the esophagus.
OBJECTIVES: I. Compare resectability and survival in patients with stage II/III esophageal cancer treated with neoadjuvant cisplatin/fluorouracil vs. surgery alone.

OUTLINE: This is a randomized study. Patients are randomized to one of two groups. The first group receives cisplatin and fluorouracil every 4 weeks for 3 courses followed by esophagectomy and regional lymphadenectomy. The second group undergoes esophagectomy and regional lymphadenectomy alone. All patients are followed for survival.

PROJECTED ACCRUAL: A total of 240 patients will be entered over 4 years.
Study Started
Jul 31
1992
Study Completion
Jun 30
2001
Last Update
Sep 20
2013
Estimate

Drug cisplatin

Drug fluorouracil

Procedure conventional surgery

Criteria 

DISEASE CHARACTERISTICS: Histologically confirmed esophageal squamous cell cancer that is stage T2-3 Nx M0

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No second malignancy within 5 years except: Basal cell skin carcinoma Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy
No Results Posted